CE Marking & Compliance to MDD, EMC, RoHS, and GPSD

[tebusse]

Hello everyone!

I may show my inexperience with question, but the time has come to ask.

I'm a single-person QA/RA unit and am putting together my first technical file documentation for a Class I, non-measuring/non-sterile device. However, the device is electronic and I understand that we have to comply with not only the MDD, but also the EMC, RoHS, and GPS directives.

Our device has been tested by a 3rd party to ensure compliance with IEC 60601, CISPR, and IEC 61000. Our suppliers are RoHS compliant. However, do I need to generate separate DoC for each directive or can all directives be listed on one DoC? Also, is it enough to document the directives in the applicable sections of my ER checklist and provide objective evidence?

Any assistance in navigating my regulatory conundrum would be most helpful.

Tonia

 

[3dBUnderThe Limit]

re: CE Marking & Compliance to MDD, EMC, RoHS, and GPSD

From my point of view you would need MDD and RoHS from your list(WEEE? Battery directive? .....).
EMC is managed 60601-1-2 and GPS direktive is can't be applicable to a Medical Device.

I would assume that you can write one DoC for all EU directives that are applicable, I have seen both types in the wild.

 

[tebusse]

Thank you.

The device does contain a rechargeable lithium ion battery, so the WEEE directive definitely applies.

The device should meet the EMC directive since it's been tested by a 3rd party (presumption of conformity).

 

[3dBUnderThe Limit]

My point for EMC is that you do not need to (should not?) claim compliance to the EMC directive, this should be a part of your 60601-1 (60601-1-2) compliance to MDD/MDR. I'm not sure if comlying to the EMC directive will be equivalent to the requirements in 60601-1-2.

For the battery I think that the battery directive is applicable as well

 

[QuinnM]

Hi Tonia,

Having one DoC is the way to go, less paperwork, easier to track, etc. Each directive identifies the requirements for a DoC. For examples see MDD 93/42/EEC annex II, and EMC 2014/30/EU annex IV. Other guidance is provided in the directives pertaining to DoCs too. When a device falls under any directive, there are requirements for DoCs, then each directive needs to be included. This is for the EU, other countries have other requirements.

Best regards,
Quinn